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FDA ANDA · ANDA214928
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: PRINSTON INC
APPLICATION
ANDA214928
TYPE
ANDA
ORIGINAL APPROVAL
2021-12-30
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2025-12-22Labeling · Supplement 3 · standardAP
2025-12-15Labeling · Supplement 2 · standardAP
2023-12-20Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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